MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0408CSS10
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To whom it may concern: on june 4, 2020, balt usa has been notified of an event regarding the use of a single optima coil (4mm x 8cm complex super soft).Details reported as follows: "rupture during coiling.Managed by temporary occlusion of parent artery with balloon micro catheter and coiling.Subarachnoid haemorrhage without symptoms." the following was provided june 17, 2020: "the hospital discharge was done on (b)(6) 2020 with mrs.= 0.No new hospitalization since the discharge.Grade 0-no symptoms at all.Grade 1-no significant disability despite symptoms, able to carry out all usual duties and activities.Grade 2-slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance.Grade 3-moderate disability, requiring some help, but able to walk without assistance.Grade 4-moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.Grade 5-severe disability, bedridden, incontinent and requiring constant nursing care and attention.Grade 6-death." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history record did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f200100050 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "rupture during coiling.Managed by temporary occlusion of parent artery with balloon micro catheter and coiling.Subarachnoid hemorrhage without symptoms.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine, ca
• MDR Report Key: 10213644
• Report Number: 3014162263-2020-00013
• Device Sequence Number: 2613754
• Product Code: HCG
• UDI-Device Identifier: 00818053021596
• UDI-Public: 00818053021596
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2022
• Device Model Number: OPTI0408CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F200100050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention